‘A harmonized, science-based legal framework is needed for NPBTs’

Coceral, the European association of trade in cereals, rice, feed oilseeds, olive oil, oils and fats, is calling for legal certainty and regulatory coherence for New Plant Breeding Techniques (NPBTs).

Its call follows the ruling last week by the EU Court of Justice (ECJ) in the case C-528/16​​, that plants obtained by directed mutagenesis, those techniques that emerged after the adoption of the EU legislation on GMO are, in principle, subject to obligations of the GMO Directive.

Coceral said that, due to the intrinsic characteristics of trade in bulk commodities, it is imperative that policymakers take into account regulatory approaches on this subject in other regions of the world in order to prevent major trade disruptions.

“As several third countries jurisdictions do not intend to regulate directed mutagenesis as GMOs, such misalignment with key trading partners would constitute yet another trade barrier that will jeopardize essential EU imports of agricultural commodities needed for the food supply in Europe, will increase food prices, and introduce a serious handicap for the development of improved varieties for the EU farming sector, leading to a structural loss of competitiveness for EU agriculture.”​

It is urging EU policymakers and EU countries to take steps to establish a harmonized, science based legal framework for NPBTs and, in particular, directed mutagenesis.

The EU Commission has not yet officially reacted to the ECJ opinion. A spokesperson only told this publication today: “We took note of last week's judgement. The Commission will now carefully assess the ruling.”​

'Significant consequences for EU innovation'

A report published by the US Department of Agriculture (USDA)​​ on the ECJ ruling noted that as the court found that plants produced with newer mutagenesis methods are subject to the regulatory obligations of the EU’s GMO Directive, they will, as such, be subject to the same risk assessment and review requirements as that applied to the cultivation and imports of transgenic varieties, whereby foreign genes are incorporated into the organism.

This decision subjects crops derived from NPBTs, and food and feed products containing such crops, to expensive and lengthy approval processes as well as traceability, labelling, and monitoring obligations. In addition to affecting global agricultural trade, this judgment has significant consequences for EU innovation, said the authors of that report.

Products approved for import in 2017 under the GMO Directive took an average of six years to complete — five years for the risk assessment by the European Food Safety Authority (EFSA) and a year to garner Commission approval through the risk management process. Cultivation approvals, as well as new applications, for transgenic varietals have languished, noted the USDA publication.

The authors of that USDA review argued that the ECJ ruling means the length of time that a new mutagenesis technique has been used is now a primary consideration determining if costly and lengthy product assessments are required, and the potential risk of the technique or the product itself is not considered.

“By not basing regulatory oversight on potential risk, agricultural breeding techniques and products that pose little or no risk will be overregulated, which will significantly discourage innovation. This is especially true for small companies and public research institutions, which lack the ability to surmount the EU’s multiyear, multistep approval process. Finally, the commercialization of these technologies globally will increase the occurrence of trade disruptions within the EU."​

Follow on actions at EU executive level will likely have to wait until after the elections, as the Commission and Parliament’s terms are coming to a close, added the author. "The Commission’s election recess starts in October 2018, and the European Parliament’s recess usually starts by March with elections following in May of 2019.” ​

'True to the science of GMOs and the law governing their release'​

Many scientists, breeders, and agri-food industry stakeholders had anticipated that the Court would categorize organisms derived from these newer mutagenic techniques as GMOs, but exempt them from the regulatory obligations in the Directive. That proved not to be the case, and while industry has expressed extreme disappointment with the judgement, some academics welcomed it. Dr Michael Antoniou, reader of molecular genetics at King's College London, commented:

"The ruling by the ECJ​ ​​shows that they have been true to both the science of GMOs and the law governing their release. Gene editing methods are undisputedly lab based genetic modification procedures and thus by definition produce GMOs that must be regulated accordingly. ​

Advocates and lobbyists for deregulation of gene edited products have argued that only the end product of the editing procedure should be considered and not the process by which it was generated, and also that the outcome is something that could occur through natural gene variation. However, these arguments are not evidence based and have simply been distorting the facts. ​

The methods by which a result is obtained are the cornerstone of experimental science. To argue that methods should be ignored and focus should only be on the end result goes against this fundamental scientific doctrine. Such thinking is tantamount to me trying to publish a set of experimental results but withholding the methods by which I obtained them, which is ridiculous.​

Taking into account the process of gene editing informs us of where things can go wrong and thus constructively informs appropriate regulation of the products of these procedures to ensure protection of the environment and health of the consumer."​